Defining AI Systems in Medical Device Regulations

This webinar provides an overview of the Commission Guidelines on the Definition of an Artificial Intelligence System, established by Regulation (EU) 2024/1689 (AI Act) with a focus in Medical and In vitro diagnostic devices. Over the webinar, key aspects of the guidelines will be examined, clarifying what should be qualified as an AI system under the new regulatory framework. The seven key points that define an AI system under this regulatory framework will be examined, offering a structured analysis of the criteria set out in the guidelines.

SPEAKER

Elisa Veronese
Auditor

Elisa has a PhD in bioengineering and nine years of experience in the world of medical device industry. She has been working with TÜV SÜD since 2023; she is active medical device lead auditor and technical documentation assessor.